Abstract
Background: Patients with high-grade symptomatic intracranial stenosis (≥70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or anticoagulant therapy. Intracranial stenting has been proposed as a viable treatment option for this high-risk patient population; however, evaluation of this therapy in randomized multicenter trials is needed. In this article, we present the design and methods of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial for symptomatic intracranial stenosis. Methods: The VISSIT trial is a randomized control study designed to evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse neurovascular balloon-expandable stent system plus medical therapy versus medical therapy alone in patients with cerebral or retinal ischemia due to neurovascular stenosis (≥70%) for preventing the primary composite end point: stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization or hard transient ischemic attack in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 postrandomization. Results: Enrollment began in February 2009 and was halted in January 2012 with 112 subjects enrolled into the study. Clinical follow-up will continue for the planned period of 12 months postrandomization. Conclusions: The VISSIT trial may provide valuable insight into the use of balloon-expandable intracranial stent as a treatment option for high-risk patients. Lessons learned from this trial may better guide future clinical trial design on best patient selection, stenting techniques, and periprocedural management.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1131-1139 |
| Number of pages | 9 |
| Journal | Journal of Stroke and Cerebrovascular Diseases |
| Volume | 22 |
| Issue number | 7 |
| DOIs | |
| State | Published - Oct 2013 |
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Keywords
- angioplasty
- balloon-mounted stent
- clinical trial
- endovascular
- intracranial stenosis
- intracranial stent
- ischemic stroke
- PHAROS stent
- stroke
- transient ischemic attack
- VISSIT
- Vitesse stent
ASJC Scopus subject areas
- Clinical Neurology
- Surgery
- Rehabilitation
- Cardiology and Cardiovascular Medicine
Cite this
Design of the vitesse intracranial stent study for ischemic therapy (VISSIT) trial in symptomatic intracranial stenosis. / Zaidat, Osama O.; Castonguay, Alicia C.; Fitzsimmons, Brian Fred; Woodward, Britton Keith; Wang, Zhigang; Killer-Oberpfalzer, Monika; Wakhloo, Ajay; Gupta, Rishi; Kirshner, Howard; Eliasziw, Misha; Thomas Megerian, J.; Shetty, Sujith; Yoklavich Guilhermier, Meg; Barnwell, Stanley; Smith, Wade S.; Gress, Daryl R.
In: Journal of Stroke and Cerebrovascular Diseases, Vol. 22, No. 7, 10.2013, p. 1131-1139.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Design of the vitesse intracranial stent study for ischemic therapy (VISSIT) trial in symptomatic intracranial stenosis
AU - Zaidat, Osama O.
AU - Castonguay, Alicia C.
AU - Fitzsimmons, Brian Fred
AU - Woodward, Britton Keith
AU - Wang, Zhigang
AU - Killer-Oberpfalzer, Monika
AU - Wakhloo, Ajay
AU - Gupta, Rishi
AU - Kirshner, Howard
AU - Eliasziw, Misha
AU - Thomas Megerian, J.
AU - Shetty, Sujith
AU - Yoklavich Guilhermier, Meg
AU - Barnwell, Stanley
AU - Smith, Wade S.
AU - Gress, Daryl R.
PY - 2013/10
Y1 - 2013/10
N2 - Background: Patients with high-grade symptomatic intracranial stenosis (≥70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or anticoagulant therapy. Intracranial stenting has been proposed as a viable treatment option for this high-risk patient population; however, evaluation of this therapy in randomized multicenter trials is needed. In this article, we present the design and methods of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial for symptomatic intracranial stenosis. Methods: The VISSIT trial is a randomized control study designed to evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse neurovascular balloon-expandable stent system plus medical therapy versus medical therapy alone in patients with cerebral or retinal ischemia due to neurovascular stenosis (≥70%) for preventing the primary composite end point: stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization or hard transient ischemic attack in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 postrandomization. Results: Enrollment began in February 2009 and was halted in January 2012 with 112 subjects enrolled into the study. Clinical follow-up will continue for the planned period of 12 months postrandomization. Conclusions: The VISSIT trial may provide valuable insight into the use of balloon-expandable intracranial stent as a treatment option for high-risk patients. Lessons learned from this trial may better guide future clinical trial design on best patient selection, stenting techniques, and periprocedural management.
AB - Background: Patients with high-grade symptomatic intracranial stenosis (≥70%) have an increased risk of recurrent stroke despite medical treatment with antiplatelet or anticoagulant therapy. Intracranial stenting has been proposed as a viable treatment option for this high-risk patient population; however, evaluation of this therapy in randomized multicenter trials is needed. In this article, we present the design and methods of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) trial for symptomatic intracranial stenosis. Methods: The VISSIT trial is a randomized control study designed to evaluate the safety, probable benefit, and effectiveness of the PHAROS Vitesse neurovascular balloon-expandable stent system plus medical therapy versus medical therapy alone in patients with cerebral or retinal ischemia due to neurovascular stenosis (≥70%) for preventing the primary composite end point: stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization or hard transient ischemic attack in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 postrandomization. Results: Enrollment began in February 2009 and was halted in January 2012 with 112 subjects enrolled into the study. Clinical follow-up will continue for the planned period of 12 months postrandomization. Conclusions: The VISSIT trial may provide valuable insight into the use of balloon-expandable intracranial stent as a treatment option for high-risk patients. Lessons learned from this trial may better guide future clinical trial design on best patient selection, stenting techniques, and periprocedural management.
KW - angioplasty
KW - balloon-mounted stent
KW - clinical trial
KW - endovascular
KW - intracranial stenosis
KW - intracranial stent
KW - ischemic stroke
KW - PHAROS stent
KW - stroke
KW - transient ischemic attack
KW - VISSIT
KW - Vitesse stent
UR - http://www.scopus.com/inward/record.url?scp=84886059476&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84886059476&partnerID=8YFLogxK
U2 - 10.1016/j.jstrokecerebrovasdis.2012.10.021
DO - 10.1016/j.jstrokecerebrovasdis.2012.10.021
M3 - Article
C2 - 23261207
AN - SCOPUS:84886059476
VL - 22
SP - 1131
EP - 1139
JO - Journal of Stroke and Cerebrovascular Diseases
JF - Journal of Stroke and Cerebrovascular Diseases
SN - 1052-3057
IS - 7
ER -